July 10, 2002 INDIANAPOLIS (AP) -- Eli Lilly and Co. said on Tuesday that regulators had agreed to let some patients use an anticancer drug on a compassionate-use basis until regulators can consider making it commercially available.
Alimta treats a rare and deadly asbestos-linked cancer called pleural mesothelioma which is most commonly seen in workers in the construction and shipbuilding trades.
Under the new program, patients newly diagnosed with pleural mesothelioma that haven't had chemotherapy or those that have already undergone chemotherapy can apply to receive the drug free of charge. Previously, the drug had only been available to those in clinical trials.
Lilly expects to apply next year for Food and Drug Administration approval to market Alimta as a treatment for mesothelioma in combination with the existing cancer drug cisplatin, spokeswoman Judy Kay Moore said.
Early test results show patients treated with an Alimta-cisplatin combination survived longer and experienced less pain and shortness of breath than those treated only with cisplatin, researchers said. The most common side effect was a decrease in infection-fighting white blood cells.
About 2,500 mesothelioma cases are diagnosed each year in the United States. The cancer of the lungs or stomach is one of the most treatment-resistant tumors and is nearly always fatal. Tumors that attach to the lung lining and chest wall expand, slowly suffocating the patient.
Barbara Ryan, an industry analyst with Deutsche Banc Alex Brown, said Alimta probably would not be a big moneymaker for Lilly unless broader treatment indications are found for the drug.
Alimta studies now under way could lead to additional uses to treat other cancers.
Lilly certainly needs a new blockbuster drug.
Lilly recently lowered its financial expectations for 2002 because of delays in the release of two new drugs and slow sales of Xigris, a new drug to treat potentially fatal blood infections.
Lilly had expected to release Cialis, for male erectile dysfunction, and atomexetine, for attention-deficit hyperactivity disorder, this year. Lilly now expects the two drugs to be released in 2003. Lilly shares closed at $49.98 on the New York Stock Exchange, down $2.11, or 4 percent.
The stock has sunk about 38 percent from a recent closing high of $80.69 on March 19.
Copyright 2002 The Associated Press. All rights reserved.
